BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUNTHER TULIP

    MDR report key: 2770061 · Received September 24, 2012

    Report

    Report Number
    2770061
    Event Type
    Malfunction
    Date Received
    September 24, 2012
    Date of Event
    August 7, 2012
    Report Date
    September 24, 2012
    Manufacturer
    COOK, INC.
    Product Code
    DTK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    DURING IVC FILTER PLACEMENT, WENT TO PREP AND LOAD THE DEVICE, AND DEVICE WOULD NOT LOAD THE WAY IT IS SUPPOSED TO. DEVICE WAS NOT USED AND THE REP WAS NOTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GUNTHER TULIP FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK COOK, INC. IGTCFS-65-1-UNI E2910741

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR